The United States Food and Drug Administration (FDA) regulates the tests that detect infection with Human Immunodeficiency Virus (HIV), the virus that causes AIDS. AIDS is a serious disease that can be fatal because the body has lost the ability to fight infections and cancers. There are a number of options for people to be tested for HIV, using tests approved by FDA:
- Trained health professionals collect a sample and run the test in a professional medical setting. You receive your test results from a trained health professional.
- You collect a sample in the home, forward the sample to a medical laboratory, and trained health professionals run the test in the medical laboratory.
- You collect a sample, run the test, and obtain your own test results in your home.
This page provides information about HIV testing, including where to find a testing site near you, and a list of the various approved assays for HIV detection.
Finding a testing site
Find an HIV testing site near where you live or work.
National HIV Testing Database
Find an HIV test site near you from the National HIV Testing Database, a CDC-sponsored service available 24 hours a day.
Approved HIV Test Kits
Clinical Laboratory Improvement Amendments (CLIA) All laboratory testing (except research) performed on humans in the U.S. is regulated under CLIA
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV Final Rule on Donor Eligibility for Human Tissues and Cells (Eligibility Determination for Donors of human Cells, Tissues, and Cellular and Tissue-Based Products) Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2